[R01] Mi Sleep Coach App for Cancer-Related Insomnia
Ente: National Cancer Institute
Scadenza: 2031-07-31
Importo max: 785.278 EUR
Paese: US
Descrizione
Project Summary
Sleep disturbances are highly prevalent among cancer survivors, with rates over 50% reported among
breast, prostate, and colorectal cancer survivors.1-3 Sleep disturbances are associated with a range of negative
effects on physical and mental health and quality of life.4 High rates of sleep medication use among survivors
lead to a range of secondary harms (e.g., fractures, increased mortality).5-7 The underlying mechanisms of
sleep disturbance among survivors are multifaceted with cancer and cancer treatment affecting the interplay
between psychological (e.g., mood, cancer-related worry, beliefs about sleep), behavioral (e.g., sleep and
activity), and physiological (e.g., increased inflammation) factors that influence sleep.8-11
Cognitive behavioral therapy for insomnia (CBT-I) is considered a first line treatment for the general
population and survivors,12-17 but access to trained professionals is severely limited.18 Digital delivery of CBT-I
(dCBT-I) using internet or mobile technologies has the potential to provide broader access at lower costs.19-21
There is a critical need to assess the efficacy of mobile dCBT-I that is designed for cancer survivors. Our Mi
Sleep Coach app is the first to employ survivor-centered design features (e.g., unique human-digital agent
interaction to extend the cancer care team, motivational interviewing to address perceived loss of control after
cancer diagnosis, just-in-time behavioral activation to modify cancer treatment-related coping behaviors that
may interfere with sleep) to deliver core CBT-I strategies. Pilot study results demonstrate high levels of
program engagement, highly positive effects on insomnia, markedly reduced use of sleep medications, and
specific associations between greater engagement with survivor-centered design features and better sleep.
The purpose of this proposal is to rigorously assess the efficacy of the Mi Sleep Coach app. We propose a
single-blinded RCT comparing Mi Sleep Coach app to a sleep education attention control app over a 7-week
period with a 6-month follow-up. We will enroll a sample of 270 patients who have completed active treatment
for breast, prostate or colorectal cancer in the NCI-funded National Clinical Trials Network. The primary
outcome is insomnia severity. Secondary outcomes include reduction in the use of sleep medications and
regulation of the neuroendocrine-inflammatory axis. Our research team, which has expertise in cancer clinical
trials, sleep disorders, digital health, inflammatory markers, and biostatistics, is well positioned to pursue the
following specific aims: Aim 1: Evaluate the efficacy of the Mi Sleep Coach app as compared to a sleep
education control app to decrease insomnia as measured by the change in the Insomnia Severity Index
(ISI). Aim 2: Evaluate the efficacy of the Mi Sleep Coach app as compared to a sleep education control app to
decrease self-reported use of sleep medications from baseline to the end of interventi
Istituzione: UNIVERSITY OF MICHIGAN AT ANN ARBOR
PI: Lawrence Chin-I An, Noel M Arring
Progetto: 1R01CA295935-01A1
Settori: National Cancer Institute
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